Trials / Completed
CompletedNCT04598113
Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients
The Immediate Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients: A Randomized Cross-over Trial)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Monastir · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
A cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Effective traction is compared to sham traction. Main outcome measures are balance parameters (force platform).
Detailed description
A cross-over randomized trial was designed to assess the immediate effect of cervical intermittent traction on balance disorders among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are treated firstly with sham traction than one week later with effective traction. At baseline the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional status (NDI), the psychological distress (HAD), the Brief Best Test and the balance parameters (force platform) are assessed. The pain intensity, the grip strength and the balance parameters are assessed before and immediately after cervical traction for comparison.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cervical Traction Device | While The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest. The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end. |
Timeline
- Start date
- 2020-11-07
- Primary completion
- 2021-03-13
- Completion
- 2021-03-20
- First posted
- 2020-10-22
- Last updated
- 2021-07-20
Locations
1 site across 1 country: Tunisia
Source: ClinicalTrials.gov record NCT04598113. Inclusion in this directory is not an endorsement.